The Bridge Clinic: Optimizing Injectable PrEP Delivery for Transgender and Non-Binary People
The Bridge Clinic:优化跨性别者和非二元性别人群的注射 PrEP 输送
基本信息
- 批准号:10619873
- 负责人:
- 金额:$ 55.08万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-04-01 至 2028-01-31
- 项目状态:未结题
- 来源:
- 关键词:AIDS preventionAddressAffectAreaArea Under CurveAwarenessBlack raceClinicClinic VisitsClinicalCommunitiesConsolidated Framework for Implementation ResearchCoupledDataDisparityDrug InteractionsDrug KineticsEducationEnrollmentEnsureEpidemicEstradiolEvidence based interventionFeedbackFriendsFrontline workerGeneral PopulationHIVHIV InfectionsHIV diagnosisHIV disparitiesHealth ProfessionalHormonesHourIndividualInfectionInjectableInjecting drug userInjectionsInsuranceInterviewLatinxMarketingMeasurementMedicalMedical RecordsMethodsModelingMonitorNewly DiagnosedNursesOralParticipantPatientsPersonsPharmaceutical PreparationsPilot ProjectsPlasmaPopulationPrevalenceProcessProtocols documentationProviderReach, Effectiveness, Adoption, Implementation, and MaintenanceReportingResearchResearch DesignResearch MethodologySan FranciscoScientific Advances and AccomplishmentsSeriesSexual PartnersStructureSurveysTestingTestosteroneTransportationUnited StatesVulnerable PopulationsWorkcis-malecohortcommunity cliniccostdrug testingflexibilitygender affirmationgender affirming hormone therapygender affirming hormoneshigh riskimplementation outcomesimplementation strategyimprovedinformantinterestintersectionalitymen who have sex with mennonbinarynovelnovel strategiespeerpeople of colorpillpractice settingpre-exposure prophylaxisprimary care clinicprimary care settingprogramssextexting supporttransgendertransgender mentransgender womenuptake
项目摘要
Project Summary/Abstract
Transgender and nonbinary (TNB) people are disproportionately affected by HIV, with increasing
numbers of new diagnoses from 2015-2019. Pre-exposure prophylaxis (PrEP) has great potential to reduce
new HIV infections, but has yet to improve HIV disparities among TNB populations. With the recent FDA
approval of long-acting injectable cabotegravir (CAB-LA) for PrEP, there is a critical opportunity to leverage this
scientific advance to increase PrEP use in TNB populations. In prior work, we piloted a flexible, low-
threshold, trans-affirming PrEP clinic (Bridge Clinic) which achieved higher PrEP uptake and reached TNB
individuals at higher risk for HIV acquisition than those receiving PrEP in gender affirming primary care clinics.
Key components of the Bridge Clinic model include a nurse-led PrEP clinic with flexible hours; PrEP
support provided by a trans peer navigator; text-messaging support via PrEPmate, a CDC-endorsed
evidence based intervention; transportation support; and a TNB community-led PrEP awareness
campaign. In this proposal, we will use Rapid-Cycle Research (RCR) methods to enhance the Bridge Clinic
to incorporate CAB-LA delivery, refine this model through iterative adaptations, and assess key implementation
outcomes. We will also evaluate for any drug interactions between gender affirming hormones and CAB-LA, an
important question to address for the TNB community. In aim 1, we will conduct a series of nominal groups
with English- and Spanish-speaking TNB people and semi-structured interviews with their providers to explore
patient- and provider-identified barriers and facilitators to CAB-LA delivery in the TNB community. We will also
elicit feedback on our implementation strategies to guide the enhancement of our protocol and engagement
approaches to incorporate CAB-LA. In aim 2, we will implement the CAB-LA Enhanced Bridge Clinic model
in an open cohort of 200 TNB individuals over a 3-year period, with mid-course adaptations guided by the RCR
process. Using the RE-AIM framework, we will assess the reach, effectiveness, adoption, implementation,
and maintenance of the Enhanced Bridge Clinic model via surveys and interviews with providers, staff, and
patients, and medical record data review. In aim 3, we will enroll a subset of participants receiving injectable
PrEP at the Bridge Clinic into two pharmacokinetic substudies to evaluate the bidirectional effects of gender
affirming hormone therapy and cabotegravir plasma concentrations in TNB individuals. Our work across aims
will be guided by a Stakeholder Advisory Board comprised of local and national community activists, leaders,
health professionals, and staff serving the TNB community who will meet quarterly to provide input on study
design and implementation, prioritization of adaptations, and ensuring the Bridge Clinic model is generalizable
to other practice settings. Upon study completion, we will have optimized and evaluated a novel PrEP delivery
model to increase uptake and persistence to long-acting injectable PrEP in TNB people, and assessed for drug
interactions between gender affirming hormones and CAB-LA in a real-world cohort of TNB individuals.
项目总结/摘要
跨性别和非二元(TNB)人群受到艾滋病毒的影响不成比例,
2015-2019年的新诊断数量。暴露前预防(PrEP)有很大的潜力,
新的艾滋病毒感染病例,但尚未改善TNB人口中艾滋病毒的不平等。最近FDA
在批准用于PrEP的长效注射用cabotegravir(CAB-LA)后,有一个关键的机会来利用这一点
科学进步,以增加在TNB人群中使用PrEP。在之前的工作中,我们试点了一种灵活的,低-
阈值,跨确认PrEP诊所(Bridge Clinic),实现了更高的PrEP摄取并达到TNB
艾滋病毒感染的风险高于那些在性别确认初级保健诊所接受PrEP的人。
桥梁诊所模式的关键组成部分包括一个护士主导的PrEP诊所,具有灵活的时间; PrEP
由跨同行导航器提供的支持;通过CDC认可的PrEPmate提供短信支持
基于证据的干预;交通支持;以及TNB社区主导的PrEP意识
运动中在本提案中,我们将使用快速循环研究(RCR)方法来增强桥梁诊所
纳入CAB-LA交付,通过迭代调整完善该模型,并评估关键实施情况
成果。我们还将评估性别肯定激素和CAB-LA之间的任何药物相互作用,
这是TNB社区需要解决的重要问题。在目标1中,我们将进行一系列的名义小组
与讲英语和西班牙语的TNB人员进行半结构化访谈,
患者和提供者确定的TNB社区CAB-LA提供的障碍和促进因素。我们还将
就我们的实施战略征求反馈意见,以指导我们加强礼宾和参与
采用CAB-LA的方法。在目标2中,我们将实施CAB-LA增强桥梁诊所模型
在一个开放的队列中,200名TNB个体在3年的时间里,在RCR的指导下进行中期适应
过程使用RE-AIM框架,我们将评估范围,有效性,采用,实施,
通过对提供者、工作人员的调查和访谈,
患者和病历数据审查。在目标3中,我们将招募一部分接受注射的参与者,
Bridge Clinic的PrEP纳入两项药代动力学子研究,以评估性别的双向影响
证实激素治疗和cabotegravir在TNB个体中的血浆浓度。我们的工作目标
将由当地和国家社区活动家,领导人,
卫生专业人员和服务于TNB社区的工作人员,他们将每季度举行一次会议,为研究提供投入
设计和实施,调整的优先级,并确保桥梁诊所模型是可推广的
到其他的实践设置。研究完成后,我们将优化和评估一种新的PrEP输送方法,
模型,以增加TNB人群对长效注射PrEP的吸收和持久性,并评估药物
在真实世界的TNB个体队列中,性别确认激素和CAB-LA之间的相互作用。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Albert Ying-Hwa Liu其他文献
Albert Ying-Hwa Liu的其他文献
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{{ truncateString('Albert Ying-Hwa Liu', 18)}}的其他基金
PrEPmate 211: Developing a mobile app to support the safe and effective use of on-demand PrEP among MSM in the US
PrEPmate 211:开发移动应用程序以支持美国 MSM 安全有效地使用按需 PrEP
- 批准号:
10242038 - 财政年份:2019
- 资助金额:
$ 55.08万 - 项目类别:
Enhancing PrEP in Community Settings (EPIC)
加强社区环境中的 PrEP (EPIC)
- 批准号:
8877312 - 财政年份:2011
- 资助金额:
$ 55.08万 - 项目类别:
Enhancing PrEP in Community Settings (EPIC)
加强社区环境中的 PrEP (EPIC)
- 批准号:
8210147 - 财政年份:2011
- 资助金额:
$ 55.08万 - 项目类别:
Enhancing PrEP in Community Settings (EPIC)
加强社区环境中的 PrEP (EPIC)
- 批准号:
8512792 - 财政年份:2011
- 资助金额:
$ 55.08万 - 项目类别:
Enhancing PrEP in Community Settings (EPIC)
加强社区环境中的 PrEP (EPIC)
- 批准号:
8685329 - 财政年份:2011
- 资助金额:
$ 55.08万 - 项目类别:
Enhancing PrEP in Community Settings (EPIC)
加强社区环境中的 PrEP (EPIC)
- 批准号:
8328887 - 财政年份:2011
- 资助金额:
$ 55.08万 - 项目类别:
Hair as a Biomarker of Tenofovir Prophylactic Exposure
头发作为替诺福韦预防性暴露的生物标志物
- 批准号:
7622701 - 财政年份:2009
- 资助金额:
$ 55.08万 - 项目类别:
Hair as a Biomarker of Tenofovir Prophylactic Exposure
头发作为替诺福韦预防性暴露的生物标志物
- 批准号:
7789426 - 财政年份:2009
- 资助金额:
$ 55.08万 - 项目类别:
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